Soft tissue repair device and associated methods

ABSTRACT

A fibrous tissue repair device includes first and second tubular anchors having corresponding longitudinal passages. The tissue repair device includes corresponding first and second inserters. Each inserter has a shaft with a distal portion received in the longitudinal passage of the corresponding tubular anchor. A flexible strand couples the first and second anchors.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.12/014,340 filed on Jan. 15, 2008, now U.S. Pat. No. 7,905,904, issuedMar. 15, 2011, which claims the benefit of U.S. Provisional ApplicationNo. 60/885,057, filed on Jan. 16, 2007, and of U.S. ProvisionalApplication No. 60/885,062, filed on Jan. 16, 2007, and which is acontinuation-in-part of the following applications:

U.S. patent application Ser. No. 11/347,661 filed on Feb. 3, 2006, nowU.S. Pat. No. 7,749,250, issued on Jul. 6, 2010;

U.S. patent application Ser. No. 11/935,681 filed on Nov. 6, 2007, nowU.S. Pat. No. 7,905,903, issued Mar. 15, 2011;

U.S. patent application Ser. No. 11/869,440 filed on Oct. 9, 2007, nowU.S. Pat. No. 7,857,830, issued on Dec. 28, 2010; which is acontinuation-in-part of U.S. patent application Ser. No. 11/408,282,filed on Apr. 20, 2006 now abandoned; and

U.S. patent application Ser. No. 11/541,506, filed on Sep. 29, 2006, nowU.S. Pat. No. 7,601,165, issued on Oct. 13, 2009.

The disclosures of the above applications are incorporated herein byreference.

INTRODUCTION

Tears caused by trauma or disease in fibrous soft tissue, such ascartilage, ligament, or muscle, can be repaired by suturing. Variousrepair devices have been developed for facilitating suturing and areeffective for their intended purposes. Nevertheless, tissue repairdevices for facilitating suturing are still desirable.

SUMMARY

The present teachings provide a fibrous tissue repair device thatincludes first and second tubular anchors having correspondinglongitudinal passages. The tissue repair device includes correspondingfirst and second inserters. Each inserter has a shaft with a distalportion received in the longitudinal passage of the correspondingtubular anchor. A flexible strand couples the first and second anchors.

In some embodiments the anchors are non deformable. In some embodiments,the tissue repair device includes a cannula having a handle and apassage receiving the first and second inserters.

In some embodiments, the fibrous repair device includes a handle, firstand second inserters movable relative to the handle, and first andsecond anchors pre-loaded on corresponding external surfaces of thefirst and second inserters. The repair device also includes a controlmechanism operable to control a deployment sequence of the first andsecond inserters for deploying the corresponding first and secondanchors, such that the second inserter is prevented from deploying thesecond anchor until the first anchor is deployed by the first inserter.

In some embodiments, the fibrous tissue repair device includes a handle,a first inserter movable relative to the handle, a first anchorpre-loaded on an external surface of the first inserter, and a firstslider coupled to the handle for moving the first inserter betweendeployment and retraction positions. The repair device can also includea second inserter movable relative to the handle, a second anchorpre-loaded on an external surface of the second inserter, and a secondslider coupled to the handle for moving the second inserter betweendeployment and retraction positions. Further, the repair device caninclude a slider control mechanism coupled to the first and secondsliders and operable to control a motion sequence of the first andsecond inserters, such that the first inserter is constrained to move toa deployment position before the second inserter. The repair device canalso include a flexible strand coupling the first and second anchors.The flexible strand can pass through portions of the first and secondanchors and form an adjustable knotless loop.

The present teachings also provide a method of repairing fibrous tissue.The method includes preloading a first anchor externally onto a firstinserter, passing the first inserter from a first side to a second sideof the fibrous tissue at a first location, delivering the first anchoron the second side of the fibrous tissue, and retracting the firstinserter away from the tissue.

Further areas of applicability of the present invention will becomeapparent from the description provided hereinafter. It should beunderstood that the description and specific examples are intended forpurposes of illustration only and are not intended to limit the scope ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from thedetailed description and the accompanying drawings, wherein:

FIG. 1 is side view of a tissue repair device according to the presentteachings;

FIG. 1A is a perspective view of a tissue repair kit according to thepresent teachings;

FIG. 2 is a perspective view of a tissue repair device according to thepresent teachings;

FIG. 3 is an enlarged perspective view of a tissue repair deviceaccording to the present teachings;

FIG. 4 is a side view of a tissue repair device according to the presentteachings shown in a first position;

FIG. 5 is a side view of the device of FIG. 4 shown in a secondposition;

FIG. 6 is an enlarged side view of a tissue repair device according tothe present teachings;

FIG. 7 is an enlarged side view of a tissue repair device according tothe present teachings;

FIG. 8 is an enlarged side view of a tissue repair device according tothe present teachings;

FIGS. 9A-C are perspective views of a flexible anchor shown withflexible strand arrangements according to the present teachings;

FIG. 9D is a perspective view illustrating a first configuration and afirst orientation of an anchor relative to soft tissue according to thepresent teachings;

FIG. 9E is a perspective view illustrating a second configuration and asecond orientation of the anchor of FIG. 9E relative to soft tissueaccording to the present teachings;

FIG. 10 is a perspective view of two pre-loaded inserters according tothe present teachings;

FIG. 11 is an environmental view illustrating inserting a first anchorthrough soft tissue according to the present teachings;

FIG. 12 is an environmental view illustrating delivering a first anchoron an outer surface of soft tissue according to the present teachings;

FIG. 13 is a perspective view illustrating connecting a flexible strandbetween first and second anchors according to the present teachings;

FIG. 14 is an environmental view illustrating delivering a second anchoron an outer surface of soft tissue according to the present teachings;

FIG. 15 is a perspective view illustrating passing a free end offlexible strand connecting first and second anchors through a slip knotaccording to the present teachings;

FIG. 15A is a perspective view illustrating first and second anchorsconnected by a flexible strand according to the present teachings;

FIG. 15B is a perspective view of a soft tissue repair device accordingto the present teachings;

FIG. 16 is an environmental view illustrating a soft tissue defectrepair with two anchors according to the present teachings;

FIG. 17 is side view of a tissue repair device according to the presentteachings;

FIG. 18 is an enlarged side view of the device of FIG. 17;

FIG. 19 is an exploded view of FIG. 17;

FIG. 20 is a perspective view of an anchor according to the presentteachings;

FIG. 21 is a perspective view of two pre-loaded inserters according tothe present teachings;

FIG. 22 is a perspective view illustrating connecting a flexible strandbetween first and second anchors according to the present teachings;

FIG. 23 is a perspective view illustrating passing a free end offlexible strand connecting first and second anchors through a slip knotaccording to the present teachings;

FIG. 24 is a perspective view of two pre-loaded inserters according tothe present teachings;

FIG. 25 is a perspective view illustrating connecting a flexible strandbetween first and second anchors according to the present teachings;

FIG. 26 is a perspective view illustrating passing a free end offlexible strand connecting first and second anchors through a slip knotaccording to the present teachings;

FIG. 26A is a perspective view illustrating first and second anchorsconnected by a flexible strand according to the present teachings;

FIG. 26B is a perspective view of a soft tissue repair device accordingto the present teachings;

FIG. 27 is an environmental view illustrating delivering a second anchoron an outer surface of soft tissue according to the present teachings;

FIGS. 28A and 28B are environmental views illustrating a soft tissuedefect repair with two anchors according to the present teachings;

FIG. 29 is partially exploded perspective view of an inserter assemblyaccording to the present teachings;

FIG. 30 is a plan view of the inserter assembly of FIG. 29;

FIG. 31 is another partially exploded view of the inserter assembly ofFIG. 29;

FIG. 32 is a detail of a partially exploded view of the inserterassembly of FIG. 29;

FIGS. 33, 34, 35 and 36 are sequential views illustrating an exemplarymethod of coupling first and second flexible anchors with a flexiblestrand, and FIG. 35A shows a detail of FIG. 35;

FIG. 37 is a view illustrating loading first and second flexible anchorson the inserter assembly of FIG. 29;

FIG. 38 is a perspective view of a flexible anchor coupled with aflexible strand;

FIG. 39A is a bottom view of an anchor according to the presentteachings;

FIG. 39B is a top view of the anchor of FIG. 39A;

FIG. 40 is a view illustrating coupling first and second anchors with aflexible strand according to the present teachings; and

FIG. 41 is a perspective view showing an anchor loaded onto an inserteraccording to the present teachings.

DESCRIPTION OF VARIOUS ASPECTS

The following description is merely exemplary in nature and is in no wayintended to limit the invention, its application, or uses. For example,although the present teachings are illustrated in an application formeniscus repair in knee surgery, the present teachings can also be usedfor repairing any fibrous tissue, such as muscle, ligament or tendon inan arthroscopic or other open procedure, including rotator cuffreconstruction, acromioclavicular (AC) reconstruction, anterior cruciateligament reconstruction (ACL) and generally for fastening tendons,grafts, or strands to fibrous tissue and bone. Additionally, the presentteachings can be used for repairing tissue in cardiological,laparoscopic, urological, plastic or other procedures.

An exemplary tissue repair device 100 according to the present teachingsis illustrated in FIG. 1, and in a kit form in FIG. 1A. The device 100can include one or more inserters 102 and a cannula 200. The inserters102 can be single-use, disposable, or sterilizable inserters. Eachinserter 102 can be externally pre-loaded on its outer or externalsurface 121 with a single flexible anchor 150, as described below. Theinserter 102 can include a handle 104 and a solid shaft 106 having asolid distal portion 108.

Referring to FIGS. 6-8, the distal portion 108 can include a sharp edge110 defined by an inclined surface 112. The distal portion 108 can alsoinclude an external groove or slot 120 which is formed in a directionthat is transverse or substantially perpendicular to the shaft 106. Thedistal portion 108 can also include two opposing substantially planarsurfaces 116 defining a buttress 118. It will be appreciated that theouter or external surface 121 of the distal portion 108 incorporates theexternal groove 120, the planar surfaces 116 and the buttress 118.

The flexible anchor 150 can be an elongated member having first andsecond ends 152, 154. The flexible anchor 150 can be made of resorbableor non-resorbable materials, including braided suture, sponges andsponge-like materials in solid form, perforated materials, woven/braidedfrom biocompatible materials or fibers, such as, for example, polymer,polyester, polyethylene, cotton, silk, or other natural or syntheticmaterials, including sponges and sponge-like materials. The flexibleanchor 150 can also be an elongated tubular or solid member or atwo-dimensional member with or without internal bores. The flexibleanchor 150 can have any properties that allow the flexible anchor 150 tochange shape. The flexible anchor 150 can be, for example, compliant,flexible, foldable, squashable, squeezable, deformable, limp, flaccid,elastic, low-modulus, soft, spongy, perforated or any other flexiblemember which can change shape. In some aspects, the flexible anchor 150can be coated with biological or biocompatible coatings, and it can alsobe soaked in platelets and other biologics, which can be easily absorbedby the flexible anchor 150 in particular when, for example, the flexibleanchor 150 is made from spongy, absorbent material.

It should be understood by the above description that the flexibleanchor 150 cannot pierce or otherwise penetrate tissue either with thefirst and second ends 152, 154 or with any portion thereof. The flexibleanchor 150 can be loaded solely on the external surface 121 of thedistal portion 108 of the shaft 106 in a folded configuration, such atthe first and second ends 152, 154 are facing each other. Accordingly,no portion of the anchor 150 is received even partially in or within theinserter, in contrast to prior art hollow needles and tubes that definean interior tubular surface within which one or more anchors are heldsubstantially in their entirety. More specifically, an intermediateportion 156 of the flexible anchor 150 can be smoothly bent in asubstantially U-shape, and draped over the external groove 120, whilethe first and second ends 152, 154 extend along the flat portions 116 ofthe shaft 106 of the inserter 102. The flexible anchor 150 can be in theform of an elongate flexible tube defining a bore 158 along its length,as shown in FIG. 9A. The flexible anchor 150 can be formed of suturebraided without a core.

Referring to FIGS. 1, 1A, and 6-8, the cannula 200 can include a handle202 and a tubular or hollow shaft 204. The shaft 204 of the cannula 200can have a longitudinal bore 220 having an inner diameter sized toreceive the shaft 106 of the inserter 102. The shaft 204 of the cannula200 can have a distal end 206 which can be perpendicular relative to theshaft 204, although it can be also be slanted relative to the shaft 204as shown in phantom line in FIG. 6. The distal end 206 of the cannula200 has a rounded, blunt or smooth edge, which is not intended to orcapable of piercing or otherwise penetrating tissue, whether the distalend 206 is slanted or perpendicular to the shaft 204.

Referring to FIG. 8, the cannula shaft 204 can include a cut-away slot208 defining a viewing window 210. The window 210 can be covered withclear plastic, for example in the form of a tubular member 212 receivedin the bore 220 of the cannula shaft 204.

Referring to FIGS. 4 and 5, the soft tissue repair device 100 can beused with a depth limiter 500. The depth limiter 500 can be installedover the shaft 106 of the inserter 102 and between the handle 104 of theinserter 102 and the handle 204 of the cannula 200. The depth limitercan operate as an actuator using, for example, a rack-and-gear mechanismto move the shaft 106 of the inserter 102 relative to the shaft 204 ofthe cannula 200 between the position shown in FIG. 4, and the positionshown in FIG. 5. In the position of FIG. 4, the inserter 102 extends adistance “D” beyond the distal end 206 of the cannula 200. In theposition of FIG. 5, the inserter 102 extends a distance “D-d” beyond thedistal end 206 of the cannula 200, where “d” is a retraction distance ofthe depth limiter 500. Alternatively, a separate disposable depthlimiter in the form of a plastic tube 200′ that can be cut to a desireddepth by removing a portion of length “d” can also be used over theshaft 106 of the inserter 102, as shown in FIG. 1A. The cannula 200, onthe other hand, can be reusable.

Referring to FIGS. 1A and 9A-9C, the flexible anchor 150 can beassembled bent in a U-shape form on the inserter 102 with a continuousstrand loop 300 attached thereon. The strand loop 300 can be formed by asingle segment of flexible strand 301 passing through the bore 158 ofthe anchor 150, such that the strand loop 300 includes a first externalsegment or portion 302 outside the bore 158 and between the ends 152,154, and a second external segment portion 304 located outside the bore158 and exiting the bore 158 from exit positions or openings 160, 162 onopposite sides of the bent U-shape of the flexible anchor 150. Theflexible strand 301 can be made of braided filaments or fibers ofbiocompatible material, including natural and synthetic fibers, such ascotton, silk, polymer, polyester, polyethylene, thin wire, suture, andother materials.

The strand loop 300 can be formed by tying the ends of the segment witha knot 306 which can be positioned on either the first external portion302 or the second external portion 304, as shown in FIGS. 9B and 9Crespectively. It will be appreciated that the loop 300 can define firstand second secondary loops or sub-loops 310, 312. The first sub-loop 310can include the first external portion 302, and the second sub-loop caninclude the second external portion 304. The first and second sub-loops310, 312 can intersect each other, and each sub-loop 310, 312 can passthrough the bent portion of the bore 158 corresponding to theintermediate portion 156 of the flexible anchor 150.

Referring to FIGS. 10-15, the soft tissue repair device 100 can be usedto repair a soft tissue defect 90, such as, for example, a tear, orother weakness in fibrous soft tissue 80, such as in meniscal tissue,cartilage, muscle or other fibrous tissue under the skin. After an outerincision is made through the skin to access the soft tissue 80, thecannula 200 can be positioned through the incision without cutting orpiercing any tissue and placed adjacent the soft tissue 80, such asfibrous meniscal tissue, and operate as an access portal for theinserter 102, as shown in FIG. 11. In the following exemplary procedure,the kit of FIG. 1A that includes first and second inserters 102 can beused with the cannula 200 to repair the soft tissue 80. The first andsecond inserters 102 and their respective features, although identical,will be distinguished for descriptive clarity by appending the letters“a” and “b”, e.g. inserters 102 a, 102 b, shafts 106 a, 106 b, etc.,when desirable for further clarity. Similarly, the associated anchors150 and their features, as well as other devices used in the procedurewill also be distinguished, by appending the letters “a” and “b”, whendesirable for further descriptive clarity.

Referring to FIG. 10, the first inserter 102 a can be assembled with thefirst anchor 150 a externally coupled thereon, as shown. A firstflexible strand 350 a having a first “free” end 352 and a second end 354can be coupled on a first threader 400 a with a slip knot 356. The firststrand 350 a can pass through the first strand loop 300 a at the secondexternal portion 304 a. The second inserter 102 b can be assembled withthe second anchor 150 b externally coupled thereon, as shown. A secondstrand 350 b coupled to a second threader 400 b can pass through thesecond strand loop 300 b at the second external portion 304 b of thesecond anchor 150 b. Accordingly, the first and second inserters 102 a,102 b can be independently pre-assembled, such that the first and secondanchors 150 a, 150 b are only connectable to each otherintra-operatively.

Referring to FIGS. 11-14, in an exemplary meniscal repair of a kneejoint, the cannula 200 can be passed through the incision into the kneejoint without piercing any fibrous tissue, except the tissue of the kneejoint capsule, and positioned adjacent the meniscus. The first inserter102 a can be passed through the cannula 200 and into the soft tissue 80or meniscus from a first side of the defect 90 until the shaft 106 a ofthe first inserter 102 a can exit a second side 82 of the soft tissue80, such as an outer surface or back side of the meniscus of the kneejoint or other outer surface of a fibrous tissue, for example. The shaft106 a of the first inserter 102 a can be sufficiently pushed through thesecond side 82 of the soft tissue 80 such that upon retraction of thefirst shaft 106 a, the first anchor 150 a can be pulled off the firstshaft 106 a by the spontaneously closing tissue and remain on the secondside 82 of the soft tissue 80 at a first location, as shown in FIG. 12.The first inserter 102 a can then be removed and discarded.

It will be appreciated that the manner and structure of thepre-assembled inserter 102 and anchor 150 allows the anchor 150 to passthrough a narrow opening or slit formed in the tissue 80 by the edge 110of the inserter 102 in a first low-profile folded configuration defininga plane “A”, as shown in FIG. 9D, and deposited in that configurationoutside the tissue 80. It will be appreciated that the flexible anchor150 is deployed in its U-shape configuration with the first and secondends 152, 154 being delivered substantially simultaneously. Further, itwill be understood that tightening the first strand loop 300 by pullingon the second external portion 304 can cause the anchor 150 to deform toa second configuration having a substantially flat round-like or knurledshape. Further pulling on the second external portion 304 can rotate thefirst anchor 150 a from a first orientation defined by plane A andsubstantially perpendicular to the outer surface 82 to a secondorientation such that the deformed anchor 150 can define a plane “B”substantially parallel to and lying on the outer surface 82 of the softtissue 80 in a substantially flat shape, as shown in FIG. 9E.

Referring to FIGS. 13 and 14, the first strand 350 a can be captured bythe second threader 400 and passed through the second external portion304 b of the second strand loop 300 b of the second anchor 150 b, whichis pre-loaded on the second inserter 102 b, as shown in FIG. 13. Thesecond inserter 102 b can be inserted through the cannula 200 which ispositioned adjacent but without piercing the fibrous tissue as describedabove, and the second anchor 150 b can be delivered to the second side82 of the soft tissue 80 at a second location, as shown in FIG. 14. Thesecond inserter 102 b can then be removed and discarded.

Referring to FIG. 15, the first strand 350 a can be captured by thefirst threader 400 a, and the free end 352 can be passed through theslip knot 356. The free end 352 of the first strand 350 a can betensioned, thereby deforming each of the anchors 150 a, 150 b to asubstantially flat round-like or knurled shape that can liesubstantially flat on the second side 82 of the soft tissue, andcompressing the defect 90. Any excess portion of the first strand 350 acan be cut off, as shown in FIG. 16. It will be appreciated that morethan two anchors 150 can be deployed using a corresponding number ofinserters 102. The additional anchors 150 can be connected with thefirst strand 350 a after the second anchor 150 b is deployed in themanner described above. Alternatively, additional anchors 150 can beconnected independently of the first and second anchors 150 a, 150 b,either in pairs or singly.

Referring to FIGS. 15A and 15B, the flexible strand 350 can bepre-loaded on the first and second anchors 150, 150 b, with the free end352 passing through the slip knot 356, as shown. The first and secondanchors 150 a, 150 b can be deployed as described above using the firstand second inserters 102 a, 102 b with the interconnected anchors 150 a,150 b assembled thereon. The bore 220 of the hollow shaft 204 of thecannula 200 can have an elongated shape, or an eight-like shape shown inphantom lines in FIG. 15A, for receiving both the first and secondinserters 102 a, 102 b sequentially or simultaneously. The handles 104a, 104 b of the first and second inserters 102 a, 102 b can havecorresponding flat surfaces 105 a, 105 b, facing one another andslidable relative to one another, such that each of the first and secondinserters 102 a, 102 b can be independently inserted into or retractedfrom the cannula bore 220 without interference or obstruction from theother.

Alternative loop arrangements for coupling and deforming flexibleanchors 150 a, 150 b are discussed below in reference with FIGS. 33-38.

Referring to FIGS. 17-26, a similar procedure can be used to repair adefect 90 in soft tissue 80 using a non-deformable or substantiallyrigid anchor 600. The anchor 600 can be made of any biocompatiblematerial, such as, for example, titanium or other non-resorbable orresorbable material, including polymeric materials and Lactosorb®commercially available from Biomet, Inc., Warsaw, Ind. Referring to FIG.20, the anchor 600 can be tubular defining a longitudinal bore 602 thatextends between first and second ends 604, 606 of the anchor 600. Thelongitudinal bore 602 can be substantially D-shaped. The ends 604, 606of the anchor 600 have blunt rounded edges substantially perpendicularto the anchor 600, such that the ends 604, 606 are not capable and notintended for piercing or penetrating tissue. The anchor 600 can furtherdefine a transverse bore 610 oriented at an angle to the longitudinalbore 602, such as, for example, 90-degrees or other suitable anglerelative to the longitudinal bore 602. A flexible strand loop 620 can bepassed through the transverse bore 610.

Alternative non-deformable anchors and loop arrangements are discussedbelow in reference with FIGS. 39A-41.

Referring to FIG. 17-19, the anchor 600 can be inserted in tissue usingan inserter 650 similar to the inserter 102 shown in FIG. 1A, butconfigured to be coupled with the anchor 600. The inserter 650 can beused with the cannula 200, as described above. The inserter 650 caninclude a handle 652, and a solid shaft 654 having a solid distalportion 656. The distal portion 656 can terminate at a sharp edge 658defined by a slanted surface 660. The distal portion 656 can include abuttress or stop 668 on which the second end 606 of the anchor 600 canabut, as shown in FIG. 18. The distal portion 656 that extends betweenthe slanted surface 660 and the buttress 668 can have a D-shapedcross-section configured to be received in the D-shaped longitudinalbore 602 of the anchor 600 in a keyed manner that does not permitrelative rotation between the anchor 600 and the shaft 654.

The inserter 650 and anchor 600 can be used for fibrous tissue repair asdescribed above in reference to FIGS. 10-16. In one exemplary procedure,illustrated in FIGS. 21-23, first and second disposable inserters 650 aand 650 b independently pre-assembled with first and second anchors 600a, 600 b, respectively, can be used. Each anchor 600 a, 600 b caninclude a corresponding strand loop 670 a, 670 b passing through eachtransverse bore 610 a, 610 b. A first flexible strand 680 having a firstor free end 682 and a second end 684 can be passed through the firststrand loop 670 a and coupled with a slip knot 686 to a first threader400 a. Similarly, a second flexible strand 680 b coupled to a secondthreader 400 b can pass through the second strand loop 670 b.

The first inserter 650 a can be passed through the cannula 200 into thesoft tissue 80 from a first side of the defect 90 until the shaft 654 aof the first inserter 650 a can exit the second side 82 of the fibroussoft tissue 80, such that upon retraction of the first shaft 654 a, thefirst anchor 650 a can be pulled off the first shaft 654 a by theclosing tissue and remain on the second side 82 of the soft tissue 80 ata first location, as shown in FIG. 27. The first inserter 650 a can thenbe removed and discarded.

The first strand 680 a can be captured intra-operatively by the secondthreader 400 b and passed through the second strand loop 670 b of thesecond anchor 600 b which is pre-loaded on the second inserter 650 b, asshown in FIG. 22. The second inserter 650 b can be inserted through thecannula 200 and the second anchor 600 b can be delivered to the secondside 82 of the soft tissue 80 at a second location, as shown in FIG. 27.The second inserter 650 b can be removed and discarded.

Referring to FIG. 23, the first strand 680 a can be captured by thefirst threader 400 a and the free end 682 can be passed through the slipknot 686. The free end 682 of the first strand 680 a can be tensioned,thereby rotating the anchors 600 a, 600 b such that each anchor 60 a,600 b is positioned with its longitudinal axis parallel to the surfaceof the second side 82 of the soft tissue 80. Tensioning the first strand680 a further can compress the defect 90. Any excess portion of thefirst strand 680 a can be cut off, as shown in FIG. 27.

Referring to FIGS. 24-26, an alternative intra-operative strandconnection for the first and second anchors 600 a, 600 b is illustratedin which strand loops such as loops 670 a, 670 b shown in FIGS. 21-23are not used. Rather, the first inserter 650 a can be assembled with thefirst strand 680 a passing through the transverse bore 610 a of thefirst anchor 600 a and coupled to the first threader 600 a, as shown inFIG. 24. Similarly, the second inserter 650 b can be also assembled withthe second strand 680 b passing through the transverse bore 610 b of thesecond anchor 600 b and coupled to the second threader 400 b. After thefirst anchor 600 a is implanted on the second side 82 of the soft tissue80 and the first inserter 650 a is removed and discarded, the firststrand 680 a can be pulled by the second threader 400 b through thetransverse bore 610 b of the second anchor 600 b, as shown in FIG. 25.After the second anchor 600 b is also implanted and the second inserter650 b removed and discarded, the free end 682 of the first strand 680 acan be captured by the first threader 400 a and passed through the slipknot 686, as shown in FIG. 26. The first strand 680 is then tensioned toreduce the defect 90, as described above and shown in FIGS. 28A and 28B.

Referring to FIGS. 26A and 26B, the flexible strand 680 can bepre-loaded on the first and second anchors 600 a, 600 b with the freeend 682 passing through the slip knot 686, as shown. The first andsecond anchors 600 a, 600 b, can be deployed as described above usingthe first and second inserters 650 a, 650 b with the interconnectedanchors 600 a, 600 b assembled thereon. The bore 220 of the hollow shaft204 of the cannula 200 can have an elongated shape, or an eight-likeshape as described in connection with FIG. 15B above. The cannula 200can be used for receiving both the first and second inserters 650 a, 650b sequentially or simultaneously, as shown in FIG. 26B. The handles 652a, 652 b of the first and second inserters 650 a, 650 b can havecorresponding flat surfaces 655 a, 655 b, facing one another andslidable relative to one another, such that each of the first and secondinserters 650 a, 650 b can be independently inserted into or retractedfrom the cannula bore 220 without interference or obstruction from theother.

Referring to FIGS. 29-32 and 37, various views of an inserter assembly800 carrying first and second inserters 102 a, 102 b, such as thosedescribed above, are illustrated. The inserter assembly 800 can beoptionally used with a cannula. The inserter assembly 800 can include ahandle 802 and first and second sliders 804 a, 804 b operable forselectively and separately moving the corresponding inserters 102 a, 102b, as described below. The handle 802 can be constructed from first andsecond handle portions 802 a, 802 b that are bonded or otherwiseattached to one another.

In one aspect, the inserter assembly 800 can also include a slidercontrol mechanism 806 between the first and second handle portions 802a, 802 b. The slider control mechanism 806 can be coupled to the firstand second sliders 804 a, 805 b and is operable to prioritize theseparate deployment of the first and second flexible anchors 150 a, 150b, which are loaded on the respective first and second inserters 102 a,102 b. The slider control mechanism 806 can include a pivotable disc 808having first and second posts or pins 810 a, 810 b on a first side and athird post or pin 812 on a second side opposite the first side, as shownin FIGS. 29, 31, and 32. The first and second posts 810 a, 810 b canmove along respective first and second curved tracks 814 a, 814 b,respectively associated with the first and second sliders 804 a, 804 b.The third post 812 can move along an associated third curved track orgroove 816 defined on an inner surface of the second handle portion 802b.

In one aspect, by the cooperation of the first and second tracks 804 a,804 b, and the disc 808, the slider control mechanism 806 can enable aforward or deployment motion of the first inserter 102 a, beforeenabling a retraction motion of the first inserter 102 a and asubsequent forward or deployment motion of the second inserter 102 b.The preferential deployment of the first inserter 102 a ensures that thefirst anchor 150 a will be deployed before the second anchor 150 b,although the first and second flexible anchors 150 a, 150 b aresubstantially identical. The second anchor 150 b is the anchorassociated with the adjustment portion 908 and from which the freesecond end 904 of the flexible strand 900 exits. As discussed above,each anchor 150 a, 150 b can be sleeve-like having first and second ends152, 154 and a longitudinal bore 158 extending between the first andsecond ends 152, 154. See also FIG. 38.

Referring to FIGS. 33-38, another aspect of coupling the flexibleanchors 150 a, 150 b with a flexible strand 900 is illustrated. Theflexible strand 900 can have first and second ends 902, 904 and can bemade of materials similar to those discussed above in reference to theflexible strand 301. The flexible strand 900 can be braided in a tubularor hollow form such that it forms an internal passage 901 along thefirst and second ends 902, 904. A small knot or other retaining device906 can be optionally formed adjacent the first end 902. It will beappreciated that the knot 906 can be entirely omitted. The flexiblestrand 900 can be passed through a first opening 160 of each flexibleanchor 150 a, 150 b, guided along the bore 158 and exit through a secondopening 162 of each flexible anchor 150 a, 150 b, as shown in FIG. 34.The openings 160, 162 can be positioned between the first and secondends 152, 154 of each flexible anchor 150 a, 150 b, at a distance of,for example one-quarter length from the ends 152, 154. Furthermore, itwill be appreciated that the openings 160, 162 can be voids in the wovenfabric of the flexible anchors 150 a, 150 b, such that the openings 160,162 do not disrupt or break the weave of flexible anchors 150 a, 150 b,when the flexible anchors 150 a, 150 b are made of braided or wovenmaterial.

After the flexible anchors 150 a, 150 b are mounted on the flexiblestrand 900, the second end 904 of the flexible strand 900 can be passedinto the internal passage 901 of the flexible strand 900 at an aperture903, guided longitudinally along the passage 901, and guided out of theflexible strand 900 at an aperture 905. The portion of the flexiblestrand 900 between apertures 901 and 905 can form an adjustment portion908 between the knot 906 and the opening 162 of the second flexibleanchor 150 b, such that the flexible strand 900 defines a singleadjustable knotless loop 910, as shown in FIGS. 35 and 35A. The secondflexible anchor 150 b can be slidably moved along the flexible strand900 until the adjustment position 908 is within the bore 158 of thesecond flexible anchor 150 b and the knot 906 is adjacent the opening160 second flexible anchor 150 b, as shown in FIG. 36. It will beappreciated, however, that the adjustment portion 908 can remain in theposition shown in FIG. 35. The adjustable knotless loop 910 isself-locking and does not require the surgeon to tie a knot during thesurgical procedure for securing the flexible strand 900. Further, oncethe adjustable knotless loop 910 is self-locked by pulling the secondend 904 of the flexible strand 900 and tensioning the flexible strand900, friction prevents the adjustable knotless loop 910 from beingloosened, thereby providing a secure lock. Additional details regardingforming the knotless adjustable loop 910 and other adjustable knotlessloop configurations are disclosed in co-pending and commonly assignedU.S. patent application Ser. No. 11/541,506, filed on Sep. 29, 2006, thedisclosure of which is incorporated herein by reference.

The first flexible anchor 150 a can be loaded on the first inserter 102a, and second flexible anchor 150 b can be loaded on the second inserter102 b, as shown in FIG. 37. The first and second anchors 150 a, 150 bcan be loaded externally on their respective inserters in the mannerdiscussed in reference with FIG. 13, above. Specifically, each of thefirst and second flexible anchors 150 a, 150 b can be draped over theexternal groove 120 in the distal portion of the corresponding inserter102 a, 102 b. The inserter assembly 800 can be loaded with the first andsecond flexible anchors 150 a, 150 b coupled with the flexible strand900, which forms the closed adjustable knotless loop 910. The adjustableknotless loop 910 allows tightening the strand 900, deforming the firstand second flexible anchors 150 a, 150 b for anchoring and shorteningthe length of the adjustable knotless loop 910 without using a slipknot.The inserter assembly 800 can be used for repairing soft tissue 80, suchas a meniscus tear 90, in a similar manner as discussed with referenceto FIG. 14. The first slider 804 a can be moved forward to deploy thefirst flexible anchor 150 a at an outer surface 82 of the soft tissue.The first slider 804 a can then be moved backward, enabling the secondslider 804 b to be moved forward to deploy the second flexible anchor150 b at the outer surface 82 of the soft tissue, and adjacent the firstflexible anchor 150 a. Pulling the second end 904 of the flexible strand900 tightens the adjustable knotless loop 910, secures the first andsecond flexible anchors 150 a, 150 b against the outer surface 82 of thesoft tissue 80 and reduces the defect 90. Further, the portions of thesleeve between the first and second ends 152, 154 of each of theflexible anchors 150 a, 150 b and the corresponding first and secondopenings 160, 162, define anchoring leg portions that provide additionalresistance for securing the flexible anchors 150 a, 150 b on the outersurface 82 of the soft tissue 80, as these leg portions are forcedagainst the outer surface 82 for anchoring.

Referring to FIGS. 39A-41, another non-deformable or substantially rigidanchor 1000 is illustrated. Similarly to the anchor 600 illustrated inFIG. 20, the anchor 1000 can be made of any biocompatible material, suchas, for example, titanium or other non-resorbable or resorbablematerial, including polymeric materials and Lactosorb® commerciallyavailable from Biomet, Inc., Warsaw, Ind., and can be used in a similarmanner to repair a soft tissue defect 90. The anchor 1000 can be tubulardefining a longitudinal bore 1002 that extends between first and secondends 1004, 1006 of the anchor 600 and has an open, channel-likecross-section defining an arc of 180 degrees or more. The ends 1004,1006 of the anchor 1000 have blunt rounded edges substantiallyperpendicular to the anchor 1000, such that the ends 1004, 1006 are notcapable and not intended for piercing or penetrating tissue. The anchor1000 can further define first and second transverse through bores 1010oriented substantially perpendicularly to the anchor 1000. A flexiblestrand 900 can be passed through the transverse bores 1010 and couplefirst and second anchors 1000 a, 1000 b, as shown in FIG. 40. The strand900 can be tightened with an adjustable knotless loop 910 by pulling onfree end 904 and without the use of slipknot, as discussed above.

The first and second anchors 1000 a, 1000 b, coupled with the flexiblestrand 900, can be mounted on two separate inserters, as described abovein connection with anchors 600. An exemplary inserter 1050 loaded withthe anchor 1000 a is shown in FIG. 41. Two such inserters 1050 can beused with the inserter assembly 800 of FIG. 29, replacing the inserters102 a, 102 b. Each inserter 1050 can have a cylindrical body 1052, apointed tip 1054, and a stop 1056. The first anchor 1000 a can bemounted externally onto the body 1052 of the inserter 1050 between thetip 1054 and the stop 1056, such that that a portion of the inserter1050 is received in the longitudinal bore 1002 of the first anchor 1000a. The second anchor 1000 b can be similarly mounted on another inserter1050. Each anchor 1000 a and 1000 b can be optionally mounted in a keyedmanner onto the corresponding inserter 1050, such that accidentalrelative rotation is substantially prevented.

It will be appreciated from the above description and drawings that thepresent teachings provide anchors of versatile configurations that canbe passed through fibrous tissue easily in a compact or low profileconfiguration and or orientation and then positioned outside the fibroustissue in a second orientation that provides anchoring without tissuepenetration, prevents withdrawal from the tissue and reduces tissueinjury. Additionally, the inserter of the present teachings does notrequire an active expeller or other additional pusher rod to deploy theanchor. Rather, and because the anchor is carried solely on the externalsurface of the inserter, the anchor is deployed passively outsidefibrous tissue upon retraction of the inserter. Further, the use of adisposable or single use inserter provided with a preassembled anchorcan help reduce the time length of the procedure and simplifymanipulations required during the procedure.

It will be further understood that the various embodiments of theinserters, anchors and coupling arrangements can be mixed and matched orcombined in ways other than those explicitly discussed above, withoutdeparting from the scope of the present teachings.

The foregoing discussion discloses and describes merely exemplaryarrangements of the present invention. One skilled in the art willreadily recognize from such discussion, and from the accompanyingdrawings and claims, that various changes, modifications and variationscan be made therein without departing from the spirit and scope of theinvention as defined in the following claims.

1. A fibrous tissue repair device comprising: a first tubular anchordefining a longitudinal passage between first and second ends; a firstinserter having a longitudinal shaft along a longitudinal axis with abuttress transverse to the longitudinal axis for abutting on the firsttubular anchor and a distal portion extending from the buttress andhaving an elongated planar surface transverse to the buttress and keyedto a planar surface of the longitudinal passage of the first tubularanchor, the distal portion received in the longitudinal passage of thefirst tubular anchor; a second tubular anchor defining a longitudinalpassage between first and second ends; a second inserter having alongitudinal shaft having distal portion received in the longitudinalpassage of the second tubular anchor; and a flexible strand coupling thefirst and second tubular anchors.
 2. The repair device of claim 1,wherein the longitudinal passage of each of the first and second tubularanchors is D-shaped.
 3. The repair device of claim 1, wherein theflexible strand passes through corresponding first and second bores ofthe first and second tubular anchors.
 4. The repair device of claim 3,wherein each of the first and second bores is at an angle relative tothe longitudinal passages of the corresponding first and second tubularanchors.
 5. The repair device of claim 1, wherein each of the first andsecond tubular anchors has a circular cross-section.
 6. The repairdevice of claim 1, wherein each of the first and second inserters passesthrough a cannula having a handle.
 7. The repair device of claim 6,wherein each of the first and second inserters includes correspondingfirst and second handles coupled to the corresponding longitudinalshafts.
 8. The repair device of claim 7, wherein the first and secondhandles include corresponding first and second flat surfaces.
 9. Therepair device of claim 6, wherein the cannula has an elongatedcross-section.
 10. A fibrous tissue repair device comprising: a firstnon-deformable anchor having a first longitudinal passage; a firstinserter having a first longitudinal shaft with a distal portionreceived in the first longitudinal passage of the first non-deformableanchor and a proximal portion coupled to a first handle; a secondnon-deformable anchor having a second longitudinal passage; a secondinserter having a second longitudinal shaft having distal portionreceived in the second longitudinal passage of the second non-deformableanchor and a proximal portion coupled to a second handle; a flexiblestrand coupling the first and non-deformable second anchors; and acannula having a third handle and a longitudinal passage with anelongated cross-section slidably receiving the first and secondlongitudinal shafts; wherein the first and second handles havecorresponding first and second elongated flat surfaces facing oneanother and forming a symmetric cylindrical handle when in contact, thefirst and second flat surfaces are configured for sliding relatively toone another.
 11. The repair device of claim 10, wherein the cannula hasan elongated cross-section.
 12. The repair device of claim 10, whereinthe flexible strand forms an adjustable loop.
 13. The repair device ofclaim 10, wherein each of the first and second inserters includes a stopfor the corresponding of first and second non-deformable anchors. 14.The repair device of claim 10, wherein the first and secondnon-deformable anchors have circular cross-sections.
 15. The repairdevice of claim 14, wherein each of the first and second non-deformableanchors include corresponding first and second transverse bores.
 16. Therepair device of claim 15, wherein the flexible strand passes throughfirst and second transverse bores of the corresponding first and secondnon-deformable anchors.
 17. The repair device of claim 10, wherein thefirst and second longitudinal passages have D-shaped cross-sections. 18.A fibrous tissue repair device comprising: a first tubular anchor havinga longitudinal axis and defining a longitudinal passage between firstand second ends, the longitudinal passage having a D-shapedcross-section; a first inserter having a longitudinal shaft with abuttress for the first tubular anchor and a D-shaped distal portionhaving a longitudinal planar surface transverse to the buttress andextending distal from the buttress, the distal portion received andkeyed in the longitudinal passage of the first tubular anchor; aflexible strand passing through a transverse bore of the first tubularanchor, the transverse bore perpendicular the longitudinal axis of thefirst tubular anchor; a second tubular anchor defining a longitudinalpassage between first and second ends, the longitudinal passage having aD-shaped cross-section; a second inserter having a longitudinal shaftwith a distal portion received in the longitudinal passage of the secondtubular anchor, the second inserter having a buttress for the secondtubular anchor; and wherein the flexible stand passes through atransverse bore of the second tubular anchor.